Synacthen Depot^® (Suspension) Instructions for Use

Marketing Authorization Holder

Novartis Pharma AG (Switzerland)

Manufactured By

Nycomed Austria, GmbH (Austria)

ATC Code

H01AA02 (Tetracosactide)

Active Substance

Tetracosactide (Rec.INN registered by WHO)

Dosage Form

Synacthen® Depot

Suspension for intramuscular administration 1 mg/1 ml: amp. 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Excipients : zinc chloride, sodium phosphate, sodium chloride, benzyl alcohol (preservative), sodium hydroxide, water for injection.

1 ml – ampoules (1) – cardboard packs.
1 ml – ampoules (10) – cardboard packs.

Clinical-Pharmacological Group

ACTH analogue

Pharmacotherapeutic Group

ACTH

Pharmacological Action

Synthetic polypeptide possessing the properties of endogenous ACTH. It stimulates the initial phases of steroid hormone synthesis (including cortisol, cortisone, substances with weak androgenic activity, and a small amount of aldosterone) from cholesterol in the adrenal glands when their function is initially normal.

In patients with primary adrenal insufficiency, Tetracosactide does not cause a significant increase in plasma cortisol concentration. In patients with secondary adrenal insufficiency associated with ACTH deficiency, the use of tetracosactide compensates for the existing hormone deficiency.

In the treatment of other conditions sensitive to ACTH, the effects of ACTH are due to the action of endogenous corticosteroids produced under its influence.

It has anti-inflammatory, anti-allergic, and immunosuppressive effects, inhibits the development of connective tissue, and affects carbohydrate, fat, protein, and mineral metabolism.

Pharmacokinetics

V_d is 0.4 l/kg.

In plasma, Tetracosactide is broken down by plasma endopeptidases into inactive oligopeptides, and then, with the participation of aminopeptidases, into free amino acids. 95-100% of radiolabeled tetracosactide is excreted in the urine within 24 hours.

After intravenous administration, the elimination process occurs in 3 phases, with T_1/2 averaging 7 min, 37 min, and 3 h, respectively.

Indications

Multiple sclerosis (exacerbation); infantile myoclonic encephalopathy with hypsarrhythmia; rheumatic diseases and diffuse connective tissue diseases (in case of intolerance to oral corticosteroids, insufficient effectiveness of corticosteroids); true pemphigus, true eczema of severe chronic course, psoriasis (erythrodermic or pustular form); ulcerative colitis, isolated enteritis, kidney diseases (nephrotic syndrome); as an additional agent to improve tolerance to chemotherapy in oncological diseases; for diagnostic purposes in case of suspected adrenal cortex hypofunction.

ICD codes

Dosage Regimen

Administer Synacthen Depot intramuscularly only. The dosage is individualized based on the specific indication and patient response.

For therapeutic use in adults, a typical dose is 1 mg (1 ml) daily for several days, followed by a maintenance dose of 1 mg every 2-3 days. Alternatively, administer 1 mg daily for 7-10 days.

For pediatric patients, the dose is 0.5 mg (0.5 ml) administered once daily. Adjust the frequency and duration of therapy according to clinical response.

For diagnostic use in the Synacthen test, administer 0.25 mg (0.25 ml) intramuscularly or intravenously. Measure plasma cortisol levels before and 30 minutes after administration.

Do not administer to newborns, especially premature infants, due to the benzyl alcohol content. Monitor growth in children during long-term treatment. Perform regular ECG monitoring in children under 7 years of age.

Use with caution in patients with diabetes, hypertension, or renal impairment. During long-term therapy, implement a salt-restricted diet and consider potassium supplementation.

Adverse Reactions

From the endocrine system hyperglycemia, menstrual irregularities, hirsutism, petechiae, ecchymoses, skin pigmentation, Cushing’s syndrome.

From the digestive system erosive and ulcerative lesions of the gastrointestinal tract.

From metabolism hypokalemia, sodium and water retention in the body, edema, with long-term use in high doses in children – growth retardation.

From the musculoskeletal system osteoporosis, muscle weakness.

From the cardiovascular system steroid myopathy, increased blood pressure, with long-term use in high doses in children – reversible myocardial hypertrophy.

From the central nervous system mental disorders.

Allergic reactions skin rash, itching, anaphylactic reaction.

Reactions associated with immunosuppressive action decreased resistance to infectious diseases.

Local reactions hyperemia, rash, itching at the injection site.

Contraindications

Peptic ulcer of the stomach and duodenum in the acute phase, Cushing’s syndrome, primary adrenal insufficiency, refractory heart failure, acute psychosis, infectious diseases (if antibiotics are not used simultaneously), adrenogenital syndrome, pregnancy, lactation (breastfeeding), hypersensitivity to tetracosactide and/or ACTH.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation (breastfeeding).

Use in Renal Impairment

Use with caution in patients with chronic renal failure.

Pediatric Use

During long-term treatment in children, growth should be monitored, and in children under 7 years of age, ECG should be performed regularly.

Tetracosactide preparations containing benzyl alcohol should not be administered to newborns, especially premature infants, due to the risk of poisoning.

Special Precautions

Use with caution in patients with diabetes mellitus, arterial hypertension, bronchial asthma (increased risk of anaphylactic reactions), myasthenia gravis, ulcerative colitis, diverticulitis, with intestinal anastomosis, chronic renal failure, osteoporosis, tendency to thromboembolism.

Sodium and water retention in the body can be prevented with a salt-free diet. During long-term treatment, replacement therapy with potassium preparations is indicated.

Tetracosactide preparations in which the active substance is adsorbed on zinc compounds (in particular, zinc phosphate) have a prolonged action.

During long-term treatment in children, growth should be monitored, and in children under 7 years of age, ECG should be performed regularly.

Tetracosactide preparations containing benzyl alcohol should not be administered to newborns, especially premature infants, due to the risk of poisoning.

Drug Interactions

It reduces the effectiveness of hypoglycemic and antihypertensive agents. Ketoconazole weakens the stimulating effect of tetracosactide on the adrenal glands.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.